WO2021103720A1 - 一种输送导丝及治疗装置 - Google Patents

一种输送导丝及治疗装置 Download PDF

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Publication number
WO2021103720A1
WO2021103720A1 PCT/CN2020/112448 CN2020112448W WO2021103720A1 WO 2021103720 A1 WO2021103720 A1 WO 2021103720A1 CN 2020112448 W CN2020112448 W CN 2020112448W WO 2021103720 A1 WO2021103720 A1 WO 2021103720A1
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WIPO (PCT)
Prior art keywords
guide wire
delivery guide
layer member
wire according
mandrel
Prior art date
Application number
PCT/CN2020/112448
Other languages
English (en)
French (fr)
Inventor
龙平
�田�浩
候娟
Original Assignee
微创神通医疗科技（上海）有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 微创神通医疗科技（上海）有限公司 filed Critical 微创神通医疗科技（上海）有限公司
Priority to JP2022530678A priority Critical patent/JP2023503345A/ja
Priority to EP20892366.4A priority patent/EP4066795A4/en
Priority to KR1020227019985A priority patent/KR20220101669A/ko
Priority to AU2020390732A priority patent/AU2020390732B2/en
Priority to BR112022007450A priority patent/BR112022007450A2/pt
Priority to US17/779,363 priority patent/US20220401240A1/en
Priority to CA3155353A priority patent/CA3155353A1/en
Publication of WO2021103720A1 publication Critical patent/WO2021103720A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
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    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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    • A61L31/18—Materials at least partially X-ray or laser opaque
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Definitions

  • the present invention relates to the technical field of medical equipment, in particular to a conveying guide wire and a treatment device.
  • Intracranial aneurysms are mostly abnormal bulges that occur on the walls of intracranial arteries, which are the first cause of subarachnoid hemorrhage.
  • the incidence of intracranial aneurysms is second only to cerebral thrombosis and hypertensive cerebral hemorrhage, which is extremely harmful.
  • Surgical clipping method which uses metal clips to clamp the neck of the aneurysm to block the intracranial aneurysm and cerebral circulation. Flow, while restoring the normal blood supply of the tumor-bearing artery, prevent the aneurysm from bleeding.
  • the intratumoral embolization method uses embolic materials to fill the aneurysm to form a thrombus in the tumor to avoid further expansion of the tumor and rupture and bleeding.
  • Intravascular stent method implanting a stent into the blood vessel to interfere with the blood flow from the tumor-bearing artery into the aneurysm, so that the blood in the aneurysm will be blocked and stasis, thereby forming an aneurysm thrombus, and further promoting the closure of the aneurysm , To prevent the tumor from rupturing.
  • aneurysms generally grow around the cerebral artery ring, there are many important blood vessels, nerves and brain tissues around the cerebral artery ring.
  • the recurrence rate of patients is higher when only intratumoral embolization is used for treatment.
  • the most commonly used treatment method for intracranial aneurysms is endovascular stent method.
  • the treatment device for intracranial aneurysm treatment using the intravascular stent method is shown in FIG. 1.
  • the treatment device includes a delivery guide wire 10 and a delivery tube 20.
  • the delivery tube 20 has an axially penetrating inner Cavity, the stent 30 to be delivered is accommodated in the cavity and sleeved on the delivery guide wire 10, and there is an interference between the delivery guide wire 10, the stent 30 and the delivery tube 20 status.
  • a first frictional force is generated between the delivery guidewire 10 and the stent 20.
  • the first frictional force is generated between the delivery guidewire 10 and the stent 20.
  • the stent 30 can move synchronously with the delivery guide wire 10 and finally reach a predetermined position. During this process, a second frictional force opposite to the first frictional force is generated between the support 30 and the inner wall of the delivery pipe 20, so as to hinder the movement of the support 30 with the delivery guide wire 10.
  • the stent plays a role in guiding blood flow, so the stent has a high metal coverage, and the intracranial blood vessels are thin and circuitous, requiring small and flexible delivery.
  • the device delivers the stent. This means that, compared with a thicker conveying device, the fit between the stent and the conveying device is tighter, resulting in excessive second friction generated during the conveying process, making it difficult to push the stent.
  • the existing conveying guide wire 10 has a smooth outer surface.
  • part of the conveying guide wire 10 is provided with There are driving components with a relatively high coefficient of friction.
  • the setting of the driving member causes the outer diameter of the stent loaded on the delivery guide wire 10 to increase, which increases the second frictional force between the stent and the inner wall of the delivery tube 30.
  • the outer diameter of the entire treatment device may also follow suit. The increase makes it difficult for the treatment device to be used for the treatment of distal vascular disease.
  • the number or length of the driving members is too large, the flexibility of the distal end of the delivery guide wire 10 may be reduced.
  • the purpose of the present invention is to provide a delivery guide wire and a treatment device, which can reduce the difficulty of delivery of the stent.
  • the present invention provides a delivery guide wire for delivering medical implants, comprising a mandrel and a driving member arranged on the mandrel, and a recess is formed on the driving member.
  • the driving member includes a body and a groove formed on an outer surface of the body, and the groove constitutes the recessed portion.
  • the structure of the groove matches at least a part of the structure of the medical implant in a compressed state.
  • the groove and the inner surface of the medical implant in a compressed state are mirror images of each other.
  • the width of the groove is 0.0008 inches to 0.004 inches, and/or the depth of the groove is 0.0002 inches to 0.004 inches.
  • the groove includes one or more sub-grooves, and a plurality of the sub-grooves are staggered, continuously arranged or spaced on the outer surface of the body.
  • the groove spirally surrounds the axis of the body to form one or more spiral grooves on the outer surface of the body.
  • the driving member is spirally surrounded by winding wires along the axis of the mandrel to form one or more spiral structures, and two adjacent winding wires are arranged at intervals to form the recesses.
  • the winding wire is a polymer wire or a metal wire coated with a polymer coating on the surface.
  • the metal wire has developability, and/or the metal wire is a platinum-tungsten alloy wire or a platinum-iridium alloy wire.
  • the driving member includes an inner layer member and an outer layer member, wherein the inner layer member is made of a metal material and is fixedly sleeved on the mandrel; the outer layer member is made of a polymer material It is made and fixedly sleeved on the inner layer member.
  • the inner layer member has a void structure
  • the outer layer member partially or completely fills the void structure, and at least part of the outer layer member passes through the void structure and is connected to the mandrel.
  • the outer surface of the inner layer member is provided with a recess, and the recess constitutes the gap structure.
  • the inner layer member includes a plurality of coils, and the plurality of coils are sequentially arranged along the axial direction of the mandrel, and the gap structure is formed between two adjacent coils.
  • the inner layer member is a pipe network structure woven by silk threads, and the meshes of the pipe network structure constitute the void structure.
  • the diameter of the thread is less than or equal to 0.001 inches, and/or the number of weaving intersection points included in the inner layer member per inch of length is 15-50.
  • the inner layer member is at least one tubular structure, and the outer layer member partially or completely covers the inner layer member.
  • the inner layer member is a spiral structure formed by a wire spirally surrounding the axis of the mandrel, and the gap structure is formed between two adjacent turns of the wire.
  • the diameter of the wire is less than or equal to 0.001 inches, and/or the pitch of the spiral structure formed by the wire is 0.001-0.007 inches.
  • the inner layer member is made of a metal material with developability, wherein the metal material is selected from one of platinum, gold, tungsten, platinum gold alloy, platinum tungsten alloy, platinum iridium alloy, and platinum nickel alloy. kind or more.
  • the inner layer member is welded or glued to the mandrel, and/or the outer layer member wraps the inner layer member and extends to be connected with the mandrel.
  • the material of the outer layer includes any one or more of block polyetheramide resin, thermoplastic polyurethane elastomer, silica gel, nylon, and acrylic polymer.
  • the outer layer member is formed on the inner layer member by hot pressing and/or dip coating, or the inner layer member and the outer layer member are bonded.
  • At least two of the driving members are provided on the mandrel, and at least two of the driving members are arranged at intervals along the axial direction of the mandrel.
  • the distance between two adjacent driving members is 0.5 mm-150 mm.
  • the distance between two adjacent driving members is 0.5mm-5mm.
  • one or more of the driving members are provided on the mandrel, the outer diameter of the driving members is 0.01 inches-0.03 inches, and the length of each of the driving members is 0.5 mm-8 mm.
  • each driving member is 0.5 mm-4 mm.
  • the conveying guide wire further includes a first developing member and a second developing member, the first developing member is disposed at the end of the distal end of the mandrel, and the second developing member is disposed on the On the mandrel, the driving member is arranged between the first developing part and the second developing part.
  • the present invention also provides a treatment device, including a delivery tube, a medical implant, and the delivery guide wire;
  • the delivery tube has an axially penetrating inner cavity, and the inner cavity is used to accommodate the medical An implant, and the wall of the inner cavity squeezes the medical implant to make the medical implant in a compressed state;
  • the compressed medical implant is sleeved on the driving member ,
  • the medical implant is at least partially embedded in the recessed portion.
  • the radial dimension of the inner cavity ranges from 0.017 inches to 0.029 inches.
  • the medical implant is a self-expanding stent.
  • the delivery guide wire and the treatment device of the present invention have the following advantages:
  • the aforementioned treatment device includes a delivery guide wire, a medical implant, and a delivery tube.
  • the delivery guide wire includes a mandrel and a driving member arranged on the mandrel, and a recess is formed on the driving member.
  • the medical implant is delivered by the delivery guide wire, the medical implant is contained in a delivery tube, and the tube wall of the delivery tube is used to compress the medical implant, and the medical implant in the compressed state
  • the implant sleeve is set on the driving member, and the medical implant is at least partially embedded in the recess, thereby increasing the contact area between the stent and the driving member, and improving the contact between the medical implant and the driving member.
  • the friction between the delivery guide wire and the contact part of the medical implant and the delivery tube tends to be flat, thereby reducing the friction between the medical implant and the delivery tube , To reduce the difficulty of delivery of medical implants.
  • the outer diameter of the medical implant compressed in the delivery tube is reduced, and the outer diameter of the delivery tube can be reduced accordingly, so that the treatment device can reach the more distal target treatment position and expand the treatment range. , And can improve the overall flexibility of the treatment device, smoothly pass through more tortuous blood vessels, and increase the success rate of surgery.
  • the driving member includes an inner layer member and an outer layer member, the inner layer member is made of metal material, and is fixedly sleeved on the mandrel; the outer layer member is made of high It is made of molecular material and is fixedly sleeved on the inner layer member. Since the inner layer is fixed (for example, welded) on the mandrel, and the inner layer and the mandrel are made of metal materials, the bonding strength is very high, and there will be no displacement between the two.
  • the outer layer member made of polymer material and the inner layer member are fixedly connected by a specific structure, such as providing a void structure on the inner layer member, partially filling the outer layer member or completely filling the void structure so that the inner layer member and the outer layer member
  • the layer members are embedded and matched with each other; another example is that the inner layer member is covered by the outer layer member, and further extends to be connected with the mandrel, so that the outer layer member, the inner layer member and the mandrel can be tightly matched.
  • the outer layer member is arranged on the mandrel through the inner layer member, and the inner layer member and the outer layer member have a larger contact area, thereby further improving the connection strength.
  • Figure 1 is a schematic diagram of the structure of a treatment device in the prior art
  • Fig. 2 is a schematic structural diagram of a delivery guide wire according to an embodiment of the present invention, and the recessed portion is not shown in the figure;
  • Fig. 3 is a schematic structural diagram of a delivery guide wire according to an embodiment of the present invention, and the figure shows a recessed portion;
  • Fig. 4 is a schematic structural diagram of a bracket provided according to an embodiment of the present invention.
  • Fig. 5 is a schematic diagram of a deformed structure of the conveying guide wire shown in Fig. 3;
  • Fig. 6 is a schematic diagram of another deformed structure of the conveying guide wire shown in Fig. 3;
  • Fig. 7 is an enlarged schematic diagram of the position A of the conveying guide wire shown in Fig. 6;
  • Fig. 8 is a schematic diagram of still another deformed structure of the conveying guide wire shown in Fig. 3;
  • Fig. 9 is an enlarged schematic diagram of the position B of the conveying guide wire shown in Fig. 8;
  • Fig. 10 is a schematic diagram of another deformed structure of the conveying guide wire shown in Fig. 3;
  • Figure 11 is a schematic structural view of a delivery guide wire according to another embodiment of the present invention.
  • Figure 12 is a schematic structural diagram of a delivery guide wire provided by another embodiment of the present invention.
  • Fig. 13 is a schematic structural diagram of a delivery guide wire according to another embodiment of the present invention.
  • 120-driving member 120-driving member, 121-body, 122-groove, 123-gap, 124-inner piece, 125-outer piece, 126-gap structure;
  • the singular forms “a”, “an” and “the” include plural objects, and the plural form “plurality” includes two or more objects, unless the content clearly indicates otherwise.
  • the term “or” is usually used to include the meaning of “and/or”, unless the content clearly indicates otherwise, and the terms “installed”, “connected”, and “connected” shall be used. In a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected, or indirectly connected through an intermediate medium, and it can be a communication between two elements or an interaction relationship between two elements.
  • the specific meanings of the above-mentioned terms in the present invention can be understood according to specific situations.
  • the same or similar reference signs in the drawings represent the same or similar components.
  • proximal and distal refer to the relative position, relative position, and direction of elements or actions relative to each other from the perspective of the operator using the medical device, although the “proximal” and “distal”
  • end is not restrictive, but the “proximal end” usually refers to the end of the medical device that is close to the operator during normal operation, and the “distal” usually refers to the end that first enters the patient's body.
  • This embodiment provides a delivery guide wire for delivering a medical implant to a predetermined position in the patient's body.
  • the medical implant is, for example, a self-expanding stent (ie, a self-expanding stent), and the self-expanding stent may specifically be a braided stent or a cutting stent.
  • the medical implant may also be a medical embolization coil, a blood vessel blocking device, etc., which is not limited by the present invention.
  • the medical implant is a self-expanding stent as an example for introduction.
  • the self-expanding stent is always referred to as "stent".
  • the conveying guide wire 100 includes a mandrel 110 and a driving member 120 disposed on the mandrel 110, and a recess is formed on the driving member 120.
  • the stent When the stent is delivered, the stent is compressed in the lumen of a delivery tube (the stent is in a compressed state at this time), and is tightly sleeved on the driving member 120, so that the stent is opposed to the stent.
  • the driving member 120 generates radial pressure, and at least a part of the bracket is embedded in the recess. As a result, the contact area between the bracket and the driving member 120 can be greatly increased.
  • the first frictional force generated between the stent and the driving member 120 can also be greatly increased, thereby facilitating the delivery of the stent along with the delivery guide wire. 100 simultaneous movement.
  • the thickness of the braided wire used to braid the stent is different; similarly, for the cutting stent, the poles on the cutting stent also have different thicknesses.
  • the stent is Under the pressure of the delivery tube, thicker braided wires or poles can be more embedded in the recesses, so that the contact surface of the stent and the delivery tube (ie, the outer surface of the stent) tends to be flat, thereby The second friction force generated between the stent and the inner wall of the delivery tube is reduced, and the pushing resistance of the stent during delivery is reduced.
  • the conveying guide wire 100 described in this embodiment further includes a first developing member 130 and a second developing member 140.
  • the mandrel 110 has a first distal end and a first proximal end opposite to each other, the first developing element 130 may be a developing spring and is arranged at the end of the first distal end, and the second developing element 140 is arranged On the mandrel 110, the driving member 120 is disposed between the first developing member 130 and the second developing member 140, so that the bracket is disposed on the first developing member 130 and the second developing member 140. Between the second developing member 140.
  • the driving member 120 may be made of polymer materials such as silica gel, thermoplastic polyurethane elastomer rubber (TPU), polyimide, thermoplastic elastomer (Pebax), polytetrafluoroethylene (PTFE), etc. .
  • the driving member 120 may also be made of metal materials such as stainless steel, nickel-titanium alloy, platinum-tungsten alloy, and the like.
  • the mandrel 110 is provided with a plurality of the driving members 120, such as one, two, three, four, five, six, etc.
  • the specific number of the driving members 120 depends on the stent to be transported The length (that is, the size of the stent in the axial direction) is determined. Generally speaking, if the length of each driving member 120 is fixed, the greater the length of the stent, the greater the pushing resistance generated during transportation. At this time, more driving members 120 are needed to increase the delivery guide wire.
  • the first friction force between 100 and the stent ensures that the stent moves synchronously with the delivery guide wire 100.
  • each driving member 120 may be between 0.01 inches and 0.03 inches, and the length of each driving member 120 may be between 0.5 mm and 8 mm.
  • the driving member 120 The length is between 0.5mm-4mm.
  • the two or more driving members 120 are arranged at intervals along the axial direction of the mandrel 110.
  • the distance between two adjacent driving members 120 is between 0.5 mm and 150 mm, and preferably the distance is between 0.5 mm and 5 mm.
  • the number of driving members 120 provided on the mandrel 110 and the size of each driving member 120 are determined. Designing makes it easier to obtain a larger first friction force.
  • at least two spaced and shorter driving members 120 are provided on the mandrel 110, which can reduce the cost of the driving member 120.
  • the total length improves the retrievable rate of the stent (that is, the smaller the total length of the driving member 120, the higher the retrievable rate of the stent).
  • the provision of a plurality of short driving members 120 at intervals can improve the flexibility of the delivery guide wire 100 and facilitate the delivery of the guide wire 100 through tortuous blood vessels.
  • a plurality of shorter driving members 120 are used to make the driving member 120 can be made of materials with relatively large hardness (relatively low friction coefficient), which facilitates the control of tolerances and reduces the difficulty of production.
  • the driving member 120 includes a body 121, the body 121 is a hollow tubular body, and the body 121 is sleeved on the mandrel 110, the body A groove 122 is formed on the outer surface of 121, and the groove 122 constitutes the recessed portion.
  • the "groove" in this embodiment includes a long and narrow recessed structure, as well as circular, square or irregular recessed structures (ie pits). According to actual needs, the groove 122 has different forms. .
  • the structure of the groove 122 matches at least a part of the structure of the support in the compressed state.
  • the shape and position of the groove 122 match the shape and position of the stent
  • the size of the groove 122 also matches the size of the pole or braided wire of the stent, for example,
  • the width of the groove 122 is greater than, equal to, or slightly smaller than the width of the braided wire or pole, and the depth of the groove 122 (the distance between the bottom of the groove 122 and the outer surface of the body 121 at the top of the groove 122) It is greater than, equal to, or smaller than the radial dimension of the braided wire or the wave rod.
  • the width of the groove 122 is between 0.0008 inches and 0.004 inches, and the depth of the groove 122 is between 0.0002 inches and 0.004 inches. It is understandable that the width of the groove 122 corresponds to the width of the braided wire or pole of the stent.
  • the width of the braided wire refers to the width of the braided wire along the stent.
  • the size of the braided wire in the axial direction of the stent, and the width of the groove 122 refers to the size of the groove 122 in the axial direction of the stent.
  • the groove 122 may be a continuous structure formed on the outer surface of the main body 121, or may include a plurality of sub-grooves. On the outer surface of the main body 121, the plurality of sub-grooves may be arranged in a staggered manner. , Continuous arrangement or interval arrangement.
  • the stent 300 is knitted by a plurality of braided wires 310.
  • the groove 122 may include a plurality of sub-grooves, and the plurality of sub-grooves are arranged staggered so that the groove 122 and the inner surface of the bracket in the compressed state are mirror images of each other (eg 3), that is, the size and arrangement of the groove 122 match the size and arrangement of the braided wire 310 of the stent in the compressed state.
  • each of the braided wires 310 can be at least partially embedded in the recessed portion.
  • the groove 122 can be formed in a variety of ways.
  • the material of the main body 121 is a polymer material, and when the main body 121 is formed but not yet solidified, a thread is used to spiral or intertwine on the main body 121 along the axis of the main body 121, and the thread and the The surface of the body 121 is in close contact to apply a radial force to the body 121. Under the squeeze of the wire, the part where the outer surface of the body 121 contacts the wire is concavely deformed toward the axis of the body 121 to form the groove 122, and then the wire is removed.
  • the thread mentioned here can be a metal thread, a polymer thread or a thread made of other materials.
  • the wire diameter of the wire is the same as the wire diameter of the braided wire of the stent 300 that needs to be sheathed on the delivery guide wire 100.
  • the wire diameter of the wire may also be slightly larger than Or slightly smaller than the wire diameter of the braided wire of the stent 300.
  • the groove 122 may also be further processed and formed after the body 121 has been solidified and formed, for example, first heating the body 121 to soften the body 121, and then forming the groove 122 with a wire; or, After the body 121 has been solidified and formed, the groove 122 is carved on the outer surface of the body 121 using an engraving process.
  • the groove 122 may also be formed on the outer surface of the body 121 through an engraving process (for example, laser engraving).
  • a groove 122 matching the bracket may be formed on the surface of the body 121 through an engraving process.
  • the driving member 120 includes an inner layer member 124 and an outer layer member 125.
  • the inner layer member 124 is made of a metal material and is fixedly sleeved on the core.
  • the outer layer member 125 is made of polymer material, and is fixedly sleeved on the inner layer member 124.
  • the inner layer member 124 is made of metal material and can be fixed on the mandrel 110 by bonding or welding or other means.
  • the bonding strength between the two is very high, so the inner layer member 124 will not Displacement occurs on the mandrel 110, and the outer layer member 125 is connected to the mandrel 110 through the inner layer member 124, which indirectly increases the connection area between the outer layer member 125 and the mandrel 110, thereby strengthening the outer layer
  • the adhesion of the member 125 on the mandrel 110 reduces the possibility of looseness, wrinkles or displacement of the outer member 125 during the process of conveying the stent. It can be understood that there are two cases of "sleeving" described in this article.
  • the inner layer 124 is an independent component, and the two are assembled together after being processed separately.
  • the inner layer 125 and the mandrel 110 are integrally processed and formed, but the inner layer 124 protrudes from the outer surface of the mandrel 110.
  • a void structure 126 may be formed on the inner layer member 124, and the outer layer member 125 partially or completely fills the void structure 126 to increase the gap between the outer layer member 125 and the inner layer member 124.
  • the inner layer member 124 may have a variety of structural forms. Next, the preferred structure of the inner layer member 124 will be introduced in conjunction with the accompanying drawings. It should be understood that the inner layer 124 in the following embodiments is only an optional implementation manner of the present invention, and should not constitute a limitation to the present invention.
  • the inner layer member 124 includes a plurality of coils hooped on the mandrel 110, and the plurality of coils are arranged along the axial direction of the mandrel 110.
  • the coil can be made of a metal wire with a circular or oval cross section, two adjacent coils can be in contact with each other, so that a V-shaped cross section can be formed between two adjacent coils.
  • a recessed portion, the recessed portion constitutes the gap structure 126.
  • the recess may also be in the shape of a U-shaped groove, a cube, a rectangular parallelepiped, or a hemispherical pit.
  • the outer surface of the coil is formed by hot pressing and/or dipping and the like, and is shaped and cooled by a mold to form the outer layer 125.
  • the hot pressing method is specifically as follows: firstly, a polymer tube is sheathed on the inner layer member 124, and then a heat shrinkable tube is sheathed on the polymer tube, and then the heat shrinkable tube is heated and shaped by a mold. , So that the polymer tube melts and penetrates into the void structure 126 of the inner layer member 124, after the polymer material is cooled and solidified, the heat shrink tube can be removed.
  • the material of the outer layer 125 includes thermoplastic elastomers, such as block polyetheramide resin (Pebax) or thermoplastic polyurethane elastomer (TPU), any one or more of polymer materials such as silica gel, nylon, and acrylic polymer. kind of combination.
  • the polymer material fills the void structure 126, thereby increasing the contact area between the outer layer member 125 and the inner layer member 124 and strengthening the connection between the two. Even when the polymer material is not cured, it penetrates from between two adjacent coils to the surface of the mandrel 110, and at the same time, it can extend from both ends of the inner layer 124 to the core.
  • the outer layer member 125, the inner layer member 124, and the mandrel 110 can be tightly bonded to further reduce wrinkles and looseness of the outer layer member 125 , The possibility of displacement phenomenon.
  • the outer layer member may also be formed first, and the inner layer member 124 and the outer layer member 125 may be connected by means of adhesive bonding or the like.
  • a plurality of the coils can also be distributed on the mandrel at intervals, and the gap between two adjacent coils constitutes the gap structure.
  • the outer layer, The inner layer member and the mandrel are bonded to each other.
  • the inner layer member 124 is a spiral structure formed by spirally surrounding wires along the axis of the mandrel 110. Similar to the previous embodiment, for the inner layer member 124 of the spiral structure, the wires of two adjacent turns can be in contact with each other or separated from each other. In this embodiment, only one driving member 120 may be provided on the mandrel 110, or multiple driving members 120 may be provided.
  • the inner layer member 124 in this embodiment may be made of polymer wire or metal wire.
  • the spiral structure is soft and easy to bend, so that the conveying guide wire 100 as a whole has better flexibility.
  • the diameter of the wire of the inner layer member 124 in this embodiment is less than or equal to 0.001 inches.
  • the thread pitch of the spiral structure formed by the threads of the inner layer member 124 is 0.001-0.007 inch, and in some embodiments, the thread pitch is 0.004-0.007 inch.
  • the bonding strength between 124 and the mandrel 110 does not affect the flexibility of the conveying guide wire.
  • the inner layer member 124 is a pipe network structure woven by silk threads, and the meshes in the pipe network structure constitute the gaps. Structure 126.
  • only one driving member 120 may be provided on the mandrel 110, or multiple driving members 120 may be provided.
  • the wire used for weaving the inner layer member 124 should be as thin as possible, for example, the diameter of the wire (or the cross-sectional width of the wire) is less than or equal to 0.001 inches.
  • the number of weaving intersections on the inner layer member 124 per inch should not be too much.
  • the number of weaving intersections on the inner layer member 124 with a length of 1 inch can be between 15-50. between. In this way, while the driving member 120 enhances the firmness of the connection with the mandrel 110, the flexibility of the conveying guide wire 100 is not affected.
  • Fig. 10 shows a schematic diagram of another embodiment of the present invention.
  • one or more inner layer parts 124 are welded on the mandrel 110, and the inner layer parts 124 are metal tubes.
  • the metal tube is a tubular structure with a flat surface.
  • the length of the metal tube can be 0.3-2 mm to avoid affecting the flexibility of the delivery guide wire 100.
  • the outer layer member 125 can be arranged to cover all the metal pipes as a whole, and can be extended to the mandrel 110, and can also cover the bare metal pipes at the same time.
  • the part of the mandrel 110 (this part constitutes the void structure 126), or the outer layer member 125 can be arranged on a single metal tube (shown in FIG. 9), that is, a single outer layer member 125 wraps a single inner layer member 124, Different outer layer members 125 respectively wrap different inner layer members 124, and the outer layer member 125 can also partially cover the mandrel 110 between the plurality of metal tubes (this part constitutes the gap structure 126).
  • the wrapping of the outer layer member 125 to the inner layer member 124 can be achieved by dipping or hot pressing.
  • the metal tube may also be provided with pits, grooves, or through holes by means of laser etching, etc., to form more void structures 126 to further increase the outer layer member 125 and the inner layer member 124 The contact area between the two increases the strength of the connection.
  • the inner layer member 124 described in the above embodiments can be made of a metal that does not have developability, or can be made of a metal that has developability.
  • the metal having no developability includes but is not limited to stainless steel, and the metal having developability includes, but is not limited to, platinum-tungsten alloy or platinum-iridium alloy.
  • the inner layer member 124 is made of a developable metal (or called a radiopaque metal) to make the driving member 120 developable.
  • the material of the inner layer member can be selected from One or more of platinum, gold, tungsten, platinum alloy, platinum-tungsten alloy, platinum-iridium alloy and platinum-nickel alloy, such as platinum-tungsten alloy alone, platinum-iridium alloy alone, or platinum at the same time It is made of tungsten alloy and platinum-iridium alloy (for example, platinum-tungsten alloy wire and platinum-iridium alloy wire are jointly woven into the inner layer of the tube network structure).
  • platinum-tungsten alloy and platinum-iridium alloy for example, platinum-tungsten alloy wire and platinum-iridium alloy wire are jointly woven into the inner layer of the tube network structure.
  • the stent is sheathed on the delivery guide wire and compressed in a delivery tube
  • the delivery tube has a first proximal end and a first distal end opposite to each other, and the first proximal end and the first distal end are opposite to each other.
  • a developing ring (not shown in the figure) is provided on a distal end.
  • the driving member 120 is provided as two parts of the inner layer member 124 and the outer layer member 125, and the inner layer member 124 is a metal structure, and is fixed and sleeved.
  • the outer layer member 125 is made of a polymer material, and is fixedly sleeved on the inner layer member 124, and the outer layer member 125 is indirectly reinforced through the inner layer member 124
  • the binding force between the mandrel 110 and the mandrel 110 makes it difficult for the driving member 120 to loosen, fold or shift during the delivery of the stent, which improves the safety and safety of the delivery guide wire 100 during the delivery of medical implants. reliability.
  • the groove 122 on the outer surface of the outer layer 125 of the driving member 120 at least part of the compressed medical implant is embedded in the groove 122, thereby increasing the stent and the
  • the contact area of the driving member 120 increases the friction between the medical implant and the delivery guide wire 100, and can make the contact part of the medical implant and the delivery tube tend to be flat and reduce The friction between the medical implant and the delivery tube is small, and the difficulty of delivery of the medical implant is reduced.
  • the groove 122 may be a continuous groove formed on the body 121, and the continuous groove spirally surrounds the body 121 along the axis of the body 121.
  • the outer surface forms a spiral groove.
  • the groove 122 is preferably formed by wire.
  • the groove 122 may include at least two sub-grooves spaced apart on the body 121.
  • the sub-groove may have various shapes such as round, square, prismatic, etc. (that is, the sub-groove is a pit), and when the number of the sub-groove is more than two, the plurality of sub-groove It needs to be distributed on the outer surface of the body 121.
  • the groove 122 may be formed by processes such as engraving.
  • the braided point 311 where the braided wire 310 intersects has a larger radial thickness than other parts of the stent 300.
  • the knitting point 311 may be partially embedded in the sub-groove.
  • a certain position of the stent has a point with a larger radial size.
  • the radial size can be made larger Some or all of the points are embedded in the sub-groove.
  • the contact area between the braided wire or the pole of the stent 300 and the body 121 increases, so that The first frictional force between the stent 300 and the driving member 120 increases; at the same time, the overall outer diameter of the stent 300 tends to be the same, and the surface of the stent 300 in contact with the delivery tube (that is, the surface of the stent 300 The outer surface) is flatter, thereby reducing the second friction between the stent and the inner wall of the delivery tube, and reducing the pushing resistance during delivery of the stent.
  • the driving member 120 is composed of winding wires surrounding the mandrel 110.
  • the winding wire spirally surrounds multiple turns along the axis of the mandrel 110 to form a spiral structure, and there is a gap 123 between two adjacent turns of the winding wire, and the gap 123 constitutes the recessed portion.
  • the number of turns and the pitch of the winding wire can be adjusted as needed.
  • PPI for a braided stent, PPI refers to the number of braided points contained in the braided stent per unit length, where the length refers to the axis of the stent To size
  • the number of winding turns of the winding wire on the mandrel 110 can be increased, and the pitch of the thread can be reduced, so that the bracket and the driving member 120 have a larger contact area.
  • the winding wire may be a polymer wire, and the polymer wire preferably has a relatively large surface friction coefficient, which can be specifically selected according to needs.
  • the winding wire is composed of a metal wire and a polymer coating covering the outer surface of the metal wire.
  • the metal wire is a metal wire with developability such as platinum-tungsten alloy wire and platinum-iridium alloy wire.
  • the driving member 120 has developability. Since the driving member 120 is visualized, the operator can easily determine the specific position of the stent in the body during the delivery of the stent, and can further determine whether the partially released stent can be recycled into the delivery tube.
  • the conveying tube used for conveying through the stent has a second distal end and a second proximal end opposite to each other, and a third developer is provided on the second distal end.
  • the driving member 120 may also have the inner layer member 124 and the outer layer member 125 as shown in any one of FIGS. 5-9.
  • the specific structure and material can be the same as those of the above-mentioned implementation. The example is the same, so I won't repeat it here.
  • this embodiment also provides a treatment device, which includes a delivery tube, a medical implant, and the aforementioned delivery guide wire.
  • the delivery tube has an axially penetrating inner cavity for accommodating the medical implant, and the wall of the inner cavity squeezes the medical implant to make the medical implant The thing is compressed.
  • the compressed medical implant is tightly sleeved on the driving member 120, and generates a first friction force with the driving member 120, and the medical implant is at least partially embedded in the recess Section to increase the first frictional force.
  • the medical implant described here is, for example, a self-expanding stent, and specifically may be a braided stent or a cutting stent.
  • the delivery guide wire 100 described in this embodiment is preferably manufactured according to a specific medical implant. That is to say, in the process of producing the delivery guide wire 100, the medical implant to be delivered is first provided, and then the form of the driving member 120 and the recessed portion is determined according to the structure of the medical implant, and finally the delivery guide wire 100 is performed. Manufacturing.
  • the inner cavity of the delivery tube has different radial dimensions.
  • the radial dimension of the inner cavity ranges from 0.017 inches to 0.029 inches. More preferably, the radial dimension of the inner cavity is less than or equal to 0.027 inches, or the radial dimension of the inner cavity is less than or equal to 0.021 inches. Since the delivery guide wire adopts a driving member with a recessed part, the outer diameter of the medical implant in a compressed state can be reduced. Therefore, the treatment device of the present invention can use a delivery tube with a smaller radial size of the inner cavity.
  • the device can correspondingly reduce the outer diameter of the delivery tube, and a thinner delivery tube can reach more distal blood vessels or smaller lesions, expand the treatment range, and at the same time improve the overall flexibility of the treatment device, which is more conducive to passing The more tortuous blood vessels can reach the diseased site smoothly and improve the success rate of the operation.

Abstract

一种输送导丝(10,100)及治疗装置，治疗装置包括输送导丝(10,100)、医用植入物及输送管(20)，输送导丝(10,100)包括芯轴(110)和设置于芯轴(110)上的带动构件(120)，带动构件(120)上形成有凹陷部，医用植入物被输送管(20)压缩并套设在输送导丝(10,100)上，且医用植入物至少部分嵌入凹陷部中，从而增大医用植入物与输送导丝(10,100)之间的接触面积，有利于医用植入物随输送导丝(10,100)同步运动，降低输送难度。

Description

一种输送导丝及治疗装置 技术领域
本发明涉及医疗器械技术领域，具体涉及一种输送导丝及治疗装置。
背景技术
颅内动脉瘤多为发生在颅内动脉管壁上的异常膨出，是造成蛛网膜下腔出血的首位病因。在脑血管疾病中，颅内动脉瘤的发病率仅次于脑血栓和高血压脑出血，具有极大的危害。
现有技术中，用于治疗颅内动脉瘤的方法主要有以下三种：(1)外科夹闭法，采用金属夹子夹闭动脉瘤的颈部，以阻断颅内动脉瘤与脑循环血流，在恢复正常载瘤动脉供血的同时，防止动脉瘤破裂出血。(2)瘤内栓塞法，采用栓塞材料填充动脉瘤，使瘤体内形成血栓，避免瘤体进一步扩大而出现破裂出血。(3)血管内支架法，向血管内植入支架，干扰从载瘤动脉进入动脉瘤的血流，使动脉瘤中的血液出现阻滞淤积，从而形成动脉瘤血栓，并进一步促使瘤体封闭，以防止瘤体破裂。由于动脉瘤一般长于大脑动脉环的周围，而大脑动脉环周围存在诸多重要的血管、神经和脑组织。在利用外科夹闭法治疗动脉瘤时，对医生的医术要求极高，且利用外科夹闭法治疗动脉瘤的患者死亡率仍高达50％。对于大型或巨大型等复杂的动脉瘤，单纯采用瘤内栓塞法进行治疗时，患者的复发率较高。目前，对于颅内动脉瘤应用较多的治疗方法是血管内支架法。
现有技术中采用血管内支架法进行颅内动脉瘤治疗时的治疗装置如图1所示，所述治疗装置包括输送导丝10和输送管20，所述输送管20具有轴向贯通的内腔，待输送的支架30容纳于所述内腔中，并套设于所述输送导丝10上，且所述输送导丝10、所述支架30及所述输送管20之间为过盈状态。这样一来，当操作者推送输送导丝10在输送管30中移动时，所述输送导丝10与所述支架20之间产生第一摩擦力，在所述第一摩擦力的作用下，所述支架30可随所述输送导丝10同步移动，并最终达到预定位置。在此过程中所述支 架30与所述输送管20的内壁之间产生与所述第一摩擦力相反的第二摩擦力，以阻碍所述支架30随所述输送导丝10移动。由于在采用血管内支架法治疗颅内动脉瘤时，支架起到血流导向的作用，因此支架具有较高的金属覆盖率，而颅内血管细且迂回，需要采用细小且柔顺性好的输送装置对支架进行输送。这就意味着，相对于粗大的输送装置而言，支架和输送装置之间的配合更为紧密，导致在输送过程中产生的第二摩擦力过大而造成支架推送困难。
为了能够在输送管30中顺滑地推送，现有的输送导丝10均具有光滑的外表面，为了提高输送导丝10与支架30之间的第一摩擦力，部分输送导丝10上设置有具有相对较高摩擦系数的带动构件。然而，带动构件的设置导致装载在输送导丝10上的支架的外径增大，使支架与输送管30内壁之间的第二摩擦力增加，同时，整个治疗装置的外径也可能随之增加，使治疗装置难以用于远端血管病变的治疗。并且，如果设置的带动构件数量过多或长度过长，还可能导致输送导丝10远端的柔顺性降低。
发明内容
本发明的目的在于提供一种输送导丝及治疗装置，能够降低支架的输送难度。
为实现上述目的，本发明提供的一种输送导丝，用于输送医用植入物，包括芯轴和设置于所述芯轴上的带动构件，所述带动构件上形成有凹陷部。
可选地，所述带动构件包括本体和形成于所述本体之外表面的凹槽，所述凹槽构成所述凹陷部。
可选地，所述凹槽的结构与压缩态的所述医用植入物的至少部分结构相匹配。
可选地，所述凹槽与压缩态的所述医用植入物的内表面互为镜像。
可选地，所述凹槽的宽度为0.0008英寸至0.004英寸，和/或，所述凹槽的深度为0.0002英寸至0.004英寸。
可选地，所述凹槽包括一个或多个子凹槽，多个所述子凹槽交错布置、连续布置或间隔布置于所述本体的外表面上。
可选地，所述凹槽沿所述本体的轴线螺旋环绕以在所述本体的外表面形成一个或多个螺旋状凹槽。
可选地，所述带动构件由缠绕丝沿所述芯轴的轴线螺旋环绕形成一个或多个螺旋结构，且相邻两圈的所述缠绕丝间隔布置以形成所述凹陷部。
可选地，所述缠绕丝为高分子丝或者表面包覆有高分子涂层的金属丝。
可选地，所述金属丝具有显影性，和/或，所述金属丝为铂钨合金丝或铂铱合金丝。
可选地，所述带动构件包括内层件和外层件，其中，所述内层件由金属材料制成，并固定套设于所述芯轴上；所述外层件由高分子材料制成，并固定套设于所述内层件上。
可选地，所述内层件具有空隙结构，所述外层件部分或完全填充所述空隙结构，至少部分所述外层件穿过所述空隙结构与所述芯轴连接。
可选地，所述内层件的外表面设置有凹陷部，所述凹陷部构成所述空隙结构。
可选地，所述内层件包括多个线圈，多个所述线圈沿所述芯轴的轴向依次布置，相邻的两个所述线圈之间形成有所述空隙结构。
可选地，所述内层件是由丝线编织而成的管网状结构，所述管网状结构的网孔构成所述空隙结构。
可选地，所述丝线的直径小于或等于0.001英寸，和/或，每英寸长度的所述内层件上所包含的编织交点的数量为15-50。
可选地，所述内层件为至少一个管状结构，所述外层件部分或完整包覆所述内层件。
可选地，所述内层件是由丝线沿所述芯轴的轴线螺旋环绕而形成的螺旋结构，相邻两圈的所述丝线之间形成有所述空隙结构。
可选地，所述丝线的直径小于或等于0.001英寸，和/或，所述丝线形成的螺旋结构的螺距为0.001-0.007英寸。
可选地，所述内层件由具有显影性的金属材料制成，其中，所述金属材料选自铂、金、钨、铂金合金、铂钨合金、铂铱合金和铂镍合金中的一种或 多种。
可选地，所述内层件与所述芯轴焊接或胶结，和/或，所述外层件包覆所述内层件并延展至与所述芯轴连接。
可选地，所述外层件的材质包括嵌段聚醚酰胺树脂、热塑性聚氨酯弹性体、硅胶、尼龙和丙烯酸聚合物中的任一种或多种。
可选地，所述外层件通过热压和/或浸涂的方式形成于所述内层件上，或者所述内层件和所述外层件粘接。
可选地，所述芯轴上设有至少两个所述带动构件，至少两个所述带动构件沿所述芯轴的轴向间隔布置。
可选地，相邻两个所述带动构件之间的距离为0.5mm-150mm。
可选地，相邻两个所述带动构件之间的距离为0.5mm-5mm。
可选地，所述芯轴上设有一个或多个所述带动构件，所述带动构件的外径为0.01英寸-0.03英寸，每个所述带动构件的长度为0.5mm-8mm。
可选地，每个所述带动构件的长度为0.5mm-4mm。
可选地，所述输送导丝还包括第一显影件和第二显影件，所述第一显影件设置于所述芯轴的远端的端部，所述第二显影件设置于所述芯轴上，所述带动构件设置于所述第一显影件与所述第二显影件之间。
为实现上述目的，本发明还提供一种治疗装置，包括输送管、医用植入物及上述输送导丝；所述输送管具有轴向贯通的内腔，所述内腔用于容纳所述医用植入物，且所述内腔的壁对所述医用植入物产生挤压以使所述医用植入物呈压缩态；压缩态的所述医用植入物套设在所述带动构件上，且所述医用植入物至少部分嵌入所述凹陷部。
可选地，所述内腔的径向尺寸的范围为0.017英寸至0.029英寸。
可选地，所述医用植入物为自膨式支架。
与现有技术相比，本发明的输送导丝及治疗装置具有如下优点：
前述的治疗装置包括输送导丝、医用植入物及输送管，所述输送导丝包括芯轴和设置于所述芯轴上的带动构件，所述带动构件上形成有凹陷部。利用所述输送导丝输送医用植入物，所述医用植入物被容纳于输送管中，且所 述输送管的管壁用于压缩所述医用植入物，压缩态的所述医用植入物套设在所述带动构件上，且所述医用植入物至少部分嵌入所述凹陷部，从而增大所述支架与所述带动构件的接触面积，提高所述医用植入物与所述输送导丝之间的摩擦力，并可使所述医用植入物与所述输送管接触的部分趋于平整而减小所述医用植入物与所述输送管与之间的摩擦力，降低医用植入物的输送难度。同时，压缩在输送管中的医用植入物的外径减小，也可以相应地减小所述输送管的外径，使所述治疗装置能够到达更远端的目标治疗位置，扩大治疗范围，并能够提高治疗装置整体的柔顺性，顺利通过较为迂曲的血管，提高手术成功率。
同时，在一些实施方式中，所述带动构件包括内层件和外层件，所述内层件由金属材料制成，并固定套设于所述芯轴上；所述外层件由高分子材料制成，并固定套设于所述内层件上。由于内层件是固定(如焊接)在芯轴上的，且内层件与芯轴都是金属材料，结合强度非常高，二者间不会发生移位。而由高分子材料制成的外层件与内层件之间通过特定结构固定连接，如通过在内层件上设置空隙结构、外层件部分或完整填充该空隙结构使得内层件和外层件之间相互嵌入配合；又如通过外层件包覆所述内层件，并进一步延伸至与芯轴连接，使得外层件、内层件和芯轴三者之间实现紧密配合。所述外层件通过所述内层件设置在所述芯轴上，且所述内层件与所述外层件具有较大的接触面积，因而进一步提升了连接强度。以上方式均改变了现有技术中的连接方式，使得整个带动构件可牢固地固定于所述芯轴上，避免在输送支架的过程中出现带动构件松动、褶皱、移位的现象，从而提高输送导丝在输送医用植入物过程中的可靠性。
附图说明
图1是现有技术中的治疗装置的结构示意图；
图2是本发明根据一实施例所提供的输送导丝的结构示意图，图中未示出凹陷部；
图3是本发明根据一实施例所提供的输送导丝的结构示意图，图中示出 了凹陷部；
图4是本发明根据一实施例所提供的支架的结构示意图；
图5是图3所示的输送导丝的一种变形结构的示意图；
图6是图3所示的输送导丝的另一种变形结构的示意图；
图7是图6所示的输送导丝的A处放大示意图；
图8是图3所示的输送导丝的再一种变形结构的示意图；
图9是图8所示的输送导丝的B处放大示意图；
图10是图3所示的输送导丝的又一种变形结构的示意图；
图11是本发明根据另一实施例所提供的输送导丝的结构示意图；
图12是本发明根据再一实施例所提供的输送导丝的结构示意图；
图13是本发明根据又一实施例所提供的输送导丝的结构示意图。
图中：
10，100-输送导丝；
110-芯轴；
120-带动构件，121-本体，122-凹槽，123-间隙，124-内层件，125-外层件，126-空隙结构；
130-第一显影件；
140-第二显影件；
20-输送管；
30，300-支架；
310-编织丝；
311-编织点。
具体实施方式
为使本发明的目的、优点和特征更加清楚，以下结合附图对本发明作进一步详细说明。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。
如在本说明书中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，复数形式“多个”包括两个以上的对象，除非内容另外明确指出外。如在本说明书中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外，以及术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接。可以是机械连接，也可以是电连接。可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。附图中相同或相似的附图标记代表相同或相似的部件。
在本文中，术语“近端”、“远端”是从使用该医疗器械的操作者角度来看相对于彼此的元件或动作的相对方位、相对位置、方向，尽管“近端”、“远端”并非是限制性的，但是“近端”通常指该医疗设备在正常操作过程中靠近操作者的一端，而“远端”通常是指首先进入患者体内的一端。
本实施例提供了一种输送导丝，用于将医用植入物输送至患者体内的预定位置。所述医用植入物例如是自膨式支架(即自扩张支架)，所述自膨式支架具体可为编织支架或切割支架。在其他实施例中，所述医用植入物也可以是医用栓塞弹簧圈、血管封堵装置等，本发明不作限定。下文中，为便于描述，以所述医用植入物为自膨式支架为例进行介绍，为简明起见，一律以“支架”表示自膨式支架。
请参阅图2及图3，所述输送导丝100包括芯轴110和设置于所述芯轴110上的带动构件120，所述带动构件120上形成有凹陷部。
在输送支架时，所述支架被压缩于一输送管的内腔中(此时所述支架呈压缩态)，并紧密地套设于所述带动构件120上，以使所述支架对所述带动构件120产生径向压力，且所述支架的至少一部分嵌入所述凹陷部。如此一来所述支架与所述带动构件120的接触面积可大幅度增加。当操作者推动所述输送导丝100在所述输送管中轴向移动时，支架与所述带动构件120之间产生的第一摩擦力亦可大幅度增加，从而有利于支架随输送导丝100同步移动。而对于编织支架而言，用于编织所述支架的编织丝的粗细不一；同样地，对 于切割支架而言，所述切割支架上的波杆也存在粗细不一的情况，此时支架在输送管的压迫下，较粗的编织丝或波杆可更多地嵌入所述凹陷部，以使所述支架与所述输送管相接触的表面(即支架的外表面)趋于平整，从而减小支架与输送管内壁之间产生的第二摩擦力，降低支架输送时的推送阻力。
类似于传统的输送导丝，本实施例所述的输送导丝100还包括第一显影件130和第二显影件140。所述芯轴110具有相对的第一远端和第一近端，所述第一显影件130可为显影弹簧并设置于所述第一远端的端部，所述第二显影件140设置于所述芯轴110上，所述带动构件120设置于所述第一显影件130和所述第二显影件140之间，从而所述支架被设置在所述第一显影件130和所述第二显影件140之间。
在一些实施例中，所述带动构件120可采用硅胶、热塑性聚氨酯弹性体橡胶(TPU)、聚酰亚胺、热塑性弹性体(Pebax)、聚四氟乙烯(PTFE)等高分子材料制备而成。在另一些实施例中，所述带动构件120还可采用不锈钢、镍钛合金、铂钨合金等金属材料制备而成。
所述芯轴110上设有若干个所述带动构件120，例如一个、两个、三个、四个、五个、六个等，所述带动构件120的具体数量依据待输送的所述支架的长度(即所述支架在轴向上的尺寸)来确定。一般而言，如果每个所述带动构件120的长度固定，所述支架的长度越大，在输送时所产生的推送阻力就越大，此时需要更多的带动构件120以提高输送导丝100与支架之间的第一摩擦力，从而确保支架随输送导丝100同步移动。本实施例中，每个所述带动构件120的外径可介于0.01英寸至0.03英寸之间，每个所述带动构件120的长度介于0.5mm-8mm之间，优选所述带动构件120的长度介于0.5mm-4mm之间。当所述芯轴110上设置有两个以上的所述带动构件120时，两个以上的带动构件120沿所述芯轴110的轴向间隔设置。可选地，相邻两个所述带动构件120的间距介于0.5mm-150mm之间，优选该间距为0.5mm-5mm。
一方面相对于单纯依靠提高带动构件120自身的摩擦系数来增大所述第一摩擦力而言，通过对芯轴110上设置的带动构件120的数量以及对每个所述带动构件120的尺寸进行设计，更容易获得较大的第一摩擦力。另一方面， 相比于在芯轴110上设置一个连续的较长的带动构件，在所述芯轴110上设置至少两个间隔的且较短的带动构件120，可减小带动构件120的总长度，提高所述支架的可回收率(即，带动构件120的总长越小，支架的可回收率越高)。再一方面，设置多个间隔的短的带动构件120，可改善输送导丝100的柔顺性，有利于输送导丝100穿越迂曲的血管，同时采用多个较短的带动构件120，使得带动构件120可采用硬度相对较大(摩擦系数相对较低)的材料制作，从而便于控制公差，降低制作难度。可理解，此处所述的支架的可回收率是本领域的公知常识，对于本领域技术人员而言有：支架的可回收率＝(支架总长-支架近端到带动构件远端的距离)/支架总长*100％。
接下来将结合附图介绍所述带动构件120的结构。应理解，以下实施例中所述带动构件120的具体结构仅仅是本发明可选的实现方式，其不应当对发明构成限制。
请参考图2-图4，在一个实施例中，所述带动构件120包括本体121，所述本体121为空心管状体，且所述本体121套设于所述芯轴110上，所述本体121的外表面上形成有凹槽122，所述凹槽122即构成所述凹陷部。可理解，本实施例所述“凹槽”包括狭长的凹陷结构，也包括圆形、方形或不规则形的凹陷结构(即凹坑)，根据实际需要，所述凹槽122具有不同的形式。
例如，请继续参考图3，所述凹槽122的结构与压缩态的所述支架的至少部分结构相匹配。具体地，所述凹槽122的形状、位置与所述支架的形状、位置相匹配，且所述凹槽122的尺寸也与所述支架的波杆或编织丝的尺寸相匹配，例如，所述凹槽122的宽度大于、等于或略小于所述编织丝或波杆的宽度，所述凹槽122的深度(凹槽122底部与凹槽122顶部的本体121的外表面之间的距离)大于、等于或小于所述编织丝或所述波杆的径向尺寸等。根据所述支架的尺寸，所述凹槽122的宽度为0.0008英寸到0.004英寸之间，所述凹槽122的深度为0.0002英寸至0.004英寸之间。可以理解的是，所述凹槽122的宽度对应于所述支架的编织丝或波杆的宽度，例如，当支架的编织丝沿支架的周向延伸时，所述编织丝的宽度是指沿支架轴向的编织丝的尺寸，所述凹槽122的宽度则是指沿支架轴向的凹槽122的尺寸。
所述凹槽122可以是在所述本体121之外表面上形成的一个连续结构，也可以包括多个子凹槽，在所述本体121之外表面上，多个所述子凹槽可交错布置、连续布置或间隔布置。
以图4所示的支架300为例，所述支架300由多根编织丝310编织而成。对应于该支架300，所述凹槽122可包括多个子凹槽，多个所述子凹槽交错布置，以使所述凹槽122与压缩态的所述支架的内表面互为镜像(如图3所示)，即所述凹槽122的尺寸及其排布方式与压缩态的支架的编织丝310的尺寸及排布方式相匹配。当所述支架300套设在所述输送导丝100上时，每根所述编织丝310都可至少部分嵌入所述凹陷部中。
本实施例中所述凹槽122可采用多种方式成形。所述本体121的材质是高分子材料，且在所述本体121成形但尚未固化时，利用丝线沿所述本体121的轴线螺旋或交错缠绕于所述本体121上，并且所述丝线与所述本体121的表面紧密接触以对所述本体121施加径向作用力。在所述丝线的挤压下，所述本体121的外表面与所述丝线接触的部位朝向本体121的轴线凹陷变形，以形成所述凹槽122，之后去除所述丝线即可。此处所述的丝线可以是金属丝、高分子丝或其他材质的丝线。本实施例中，所述丝线的丝径与需要套设在所述输送导丝100上的支架300的编织丝的丝径相同，在其他实施例中，所述丝线的丝径也可以略大于或略小于所述支架300的编织丝的丝径。所述凹槽122也可以在所述本体121已经固化成形后进一步加工成形，例如首先通过对所述本体121加热以使所述本体121软化，之后再利用丝线形成所述凹槽122；或者，在所述本体121已固化成形后，利用雕刻工艺在所述本体121的外表面雕刻出所述凹槽122。
当所述本体121的材质是金属时，也可通过雕刻工艺(例如激光雕刻)在本体121的外表面形成所述凹槽122。
对于采用切割工艺成形的支架，可通过雕刻工艺在所述本体121的表面形成与所述支架相匹配的凹槽122。
请参考图5至图10，在一些实施方式中，所述带动构件120包括内层件124和外层件125，所述内层件124由金属材料制成，并固定套设于所述芯轴 110上，所述外层件125由高分子材料制成，并固定套设在所述内层件124上。
所述内层件124由金属材料制成，并可通过粘接或焊接或其他方式固定在所述芯轴110上，两者之间的结合强度非常高，因而所述内层件124不会在所述芯轴110上发生移位，而外层件125通过所述内层件124与芯轴110连接，间接地增大了外层件125与芯轴110的连接面积，从而增强外层件125在芯轴110上的附着力，从而减小在输送支架的过程中外层件125出现松动、褶皱或移位的可能性。可理解，本文中所述的“套设”有两种情况，其一，相对于芯轴110而言，所述内层件124是一个独立的构件，两者分别加工完成后再组装为一体；其二，在加工过程中，所述内层件125与所述芯轴110一体加工成型，但所述内层件124突出于所述芯轴110之外表面。
进一步地，所述内层件124上可形成有空隙结构126，所述外层件125部分或完全填充所述空隙结构126，以增大所述外层件125与所述内层件124之间的连接面积。
本发明实施例中，所述内层件124可以有多种结构形式，接下来本文将结合附图对所述内层件124的优选结构进行介绍。应理解，以下各实施例中的所述内层件124仅仅是本发明可选的实现方式，其不应对本发明构成限制。
如图5所示，在一个实施例中，所述内层件124包括箍设在所述芯轴110上的多个线圈，多个所述线圈沿所述芯轴110的轴向布置。本实施例中，由于线圈可采用截面为圆形或椭圆形的金属丝制作，因此相邻的两个所述线圈可相互接触，这样相邻两个线圈之间可形成截面类似于V形的凹陷部，所述凹陷部构成所述空隙结构126。在其它实施例中，根据线圈的径向截面的形状，所述凹陷部也可以是U形凹槽、立方体、长方体或半球形凹坑等形状。在所述线圈的外表面通过热压和/或浸涂等方式并通过模具定型、冷却以形成所述外层件125。热压方式具体为：首先在所述内层件124上套设一高分子管，然后再在所述高分子管外套设一热缩管，接着对所述热缩管进行加热并用模具塑形，以使所述高分子管熔融并渗入所述内层件124的空隙结构126之中，待高分子材料冷却固化后，去除所述热缩管即可。所述外层件125的材质包括热塑性弹性体，例如嵌段聚醚酰胺树脂(Pebax)或热塑性聚氨酯弹性体 (TPU)、硅胶、尼龙、丙烯酸聚合物等高分子材料中的任一种或多种的组合。所述高分子材料填充所述空隙结构126，从而增大所述外层件125与所述内层件124之间的接触面积，加强了两者间的连接。甚至于，所述高分子材料在未固化时，从相邻的两个线圈之间渗透至所述芯轴110的表面，同时也可以从所述内层件124的两端延展至所述芯轴110的表面，如此一来，所述外层件125、所述内层件124及所述芯轴110三者之间可紧密粘接，以进一步降低所述外层件125出现褶皱、松动、移位现象的可能性。在其他实施例中，也可以先形成外层件，并通过胶接等方式连接所述内层件124与所述外层件125。
在一些实施方式中，多个所述线圈还可间隔地分布在所述芯轴上，相邻两个线圈之间的间隙即构成所述空隙结构，此种情况下，所述外层件、所述内层件及所述芯轴之间均相互粘接。
请参考图6及图7所示，在本发明的另一个实施例中，所述内层件124是由丝线沿所述芯轴110的轴线螺旋环绕而成的螺旋结构。类似于前一实施例，对于该螺旋状结构的内层件124而言，相邻两圈的所述丝线之间可相互接触，也可相互分离。本实施例中，所述芯轴110上既可以只设置一个所述带动构件120，也可设置多个带动构件120。
可选地，本实施例中的内层件124可采用高分子丝或金属丝绕制。对于金属材质的内层件124而言，螺旋结构柔软易弯曲，使输送导丝100整体具有较好的柔顺性。
可选地，本实施例中的内层件124的所述丝线的直径小于或等于0.001英寸。其中，内层件124的所述丝线形成的螺旋结构的螺距为0.001-0.007inch，在一些实施方式中，螺距为0.004-0.007inch。螺距约大，胶水等越有利于进入内层件124和芯轴110之间，越有利于提高内层件124/外层件125和芯轴110的粘接强度，且在不降低内层件124与芯轴110的粘接强度的同时，不影响输送导丝的柔顺性。
请参考图8和图9，在本发明的再一个实施例中，所述内层件124是由丝线编织而成的管网状结构，所述管网状结构中的网孔构成所述空隙结构126。
本实施例中，所述芯轴110上既可以只设置一个所述带动构件120，也可 设置多个带动构件120。对于每一个带动构件120来说，用于编织所述内层件124的丝线应尽可能地细，例如所述丝线的直径(或丝线的截面宽度)小于或等于0.001英寸。另外，每一英寸的所述内层件124上的编织交点的数目不应过多，较佳地，长度为1英寸的所述内层件124上的编织交点的数目可在15-50之间。如此，所述带动构件120在增强与所述芯轴110的连接牢固度的同时，不会影响输送导丝100的柔顺性。
图10示出了本发明的又一个实施例的示意图。请参考图10，所述芯轴110上焊接有一个或多个内层件124，所述内层件124为金属管。本实施例中，所述金属管为表面平整的管状结构。该金属管是长度可为0.3-2mm，以避免影响输送导丝100的柔顺性。当所述金属管为至少两个时，所述外层件125可设置为整体包覆所有所述金属管，并可延展至芯轴110处，还可同时包覆多个金属管之间裸露的芯轴110部分(该部分构成空隙结构126)，或者所述外层件125可设置于单个金属管上(图9所示)，即单个外层件125将单个内层件124包裹住，不同的外层件125分别包裹不同的内层件124，外层件125同时还可以部分包覆多个金属管之间的芯轴110(该部分构成空隙结构126)。可采用浸涂或热压的方式实现外层件125对内层件124的包裹。
在其他实施例中，所述金属管上还可以通过激光刻蚀等方式设置有凹坑、凹槽或贯穿的孔洞，形成更多空隙结构126，以进一步增加外层件125与内层件124之间的接触面积，提升连接强度。
此外，以上各实施例所述的内层件124可采用不具有显影性的金属制作，也可以具有显影性的金属制作。所述不具有显影性的金属包括但不限于不锈钢，所述具有显影性的金属包括但不限于铂钨合金或铂铱合金。作为优选，所述内层件124采用具有显影性的金属(或称不透射线金属)制作，以使所述带动构件120具有显影性，具体而言，所述内层件的材料可选自铂、金、钨、铂金合金、铂钨合金、铂铱合金和铂镍合金中的一种或多种，例如单独采用铂钨合金制成，或单独采用铂铱合金制成，或同时采用铂钨合金及铂铱合金制成(例如采用铂钨合金丝及铂铱合金丝共同编织成所述管网状结构的内层件)。这样设置的好处是，在输送过程中，操作者可及时、准确地判断支 架是否还可以回收。具体而言，实际使用时，所述支架套设在所述输送导丝上，并压缩于一输送管中，所述输送管具有相对的第一近端和第一远端，在所述第一远端上设置有显影环(图中未示出)。在输送过程中，当所述带动构件120开始与显影环重合时，如再继续向远端推送支架，支架便不再能够回收，因此若带动构件120自身具有显影性，操作者就可通过显影装置准确地进行定位判断，极大地方便操作者的操作。
在图5-图10的实施例中，一方面，通过将所述带动构件120设置为内层件124和外层件125两部分，且所述内层件124为金属结构，并固定套设在所述芯轴110上，所述外层件125由高分子材料制成，并固定套设在所述内层件124上，通过所述内层件124间接地增强所述外层件125与所述芯轴110之间的结合力，使得在输送支架的过程中，所述带动构件120不易松动、褶皱或移位，提高输送导丝100在输送医用植入物过程中的安全性与可靠性。另一方面，通过所述带动构件120外层件125外表面上的凹槽122，将压缩态的所述医用植入物的至少部分嵌入所述凹槽122，从而增大所述支架与所述带动构件120的接触面积，提高所述医用植入物与所述输送导丝100之间的摩擦力，并可使所述医用植入物与所述输送管接触的部分趋于平整而减小所述医用植入物与所述输送管与之间的摩擦力，降低医用植入物的输送难度。
在一些实施方式中，请参阅图11，所述凹槽122可为形成于所述本体121上的连续凹槽，所述连续凹槽沿所述本体121的轴线螺旋环绕以在所述本体121的外表面形成螺旋状凹槽。本实施例中，所述凹槽122优选利用丝线形成所述凹槽122。
再如，请参阅图12，所述凹槽122可包括至少两个间隔分布在所述本体121上的子凹槽。所述子凹槽可为圆形、方形、棱形等各种形状(即所述子凹槽为凹坑)，并且当所述子凹槽的数量多于两个时，多个子凹槽根据需要分布在所述本体121的外表面上。本实施例中可通过雕刻等工艺形成所述凹槽122。
仍以图4所示的支架300为例，编织丝310相交的编织点311相比于支架300的其他部位而言具有较大的径向厚度，在将所述支架300套设于所述输送导丝100上时，所述编织点311可部分嵌入所述子凹槽中。或者，在其 他的支架中，所述支架的某一位置存在径向尺寸较大的点位，在将所述支架套设在所述输送导丝上时，可使所述径向尺寸较大的点位部分或全部嵌入所述子凹槽中。如此，当所述支架300套设在所述输送导丝100上并穿设于输送管的内腔中时，所述支架300的编织丝或波杆与所述本体121的接触面积增加，使支架300与所述带动构件120之间的第一摩擦力增大；同时，所述支架300的外径整体趋于一致，所述支架300与所述输送管相接触的表面(即支架300的外表面)更为平整，从而减小了支架与输送管内壁之间的第二摩擦力，降低支架输送时的推送阻力。
如图13所示，在本发明的另一个实施例中，所述带动构件120由环绕于所述芯轴110上的缠绕丝构成。所述缠绕丝沿所述芯轴110的轴线螺旋环绕多圈以形成螺旋状结构，且所述缠绕丝的相邻两圈之间存在间隙123，所述间隙123即构成所述凹陷部。
本实施例中，所述缠绕丝缠绕的圈数以及螺距可根据需要进行调整。例如当与该输送导丝100相匹配的支架具有较大的PPI(对于编织支架而言，PPI是指该编织支架在单位长度内所包含的编织点的数目，这里的长度是指支架的轴向尺寸)时，则可提高缠绕丝在芯轴110上的缠绕圈数，并减小螺距，以使支架与带动构件120具有更大的接触面积。
可选地，所述缠绕丝可为高分子丝，该高分子丝以具有较大的表面摩擦系数为佳，具体可根据需要选择。
可选地，所述缠绕丝由金属丝和包覆于所述金属丝外表面的高分子涂层构成。较佳地，所述金属丝为铂钨合金丝、铂铱合金丝之类的具有显影性的金属丝，这样一来，所述带动构件120便具有显影性。由于所述带动构件120具有显影性，因此在输送支架时，操作者可方便地判断支架在体内的具体位置，并可以进一步判断部分释放后的支架是否还可以回收至输送管内。具体而言，用于输送通过支架的输送管具有相对的第二远端和第二近端，且在所述第二远端上设置有第三显影件，在输送支架时，当操作者通过显影装置观察到所述带动构件120开始与第三显影件出现重合时，操作者即可判断支架不能够再进行回收。
可以理解，在图11-图12的实施例中，带动构件120也可以具有如图5-图9中任意一个所具有的内层件124和外层件125，具体结构和材料可以与上述实施例中相同，这里不再重复。
进一步地，本实施例还提供一种治疗装置，所述治疗装置包括输送管、医用植入物和如前所述的输送导丝。所述输送管具有轴向贯通的内腔，所述内腔用于容纳所述医用植入物，且所述内腔的壁对所述医用植入物产生挤压以使所述医用植入物被压缩。被压缩后的所述医用植入物紧密地套设在所述带动构件120上，并与所述带动构件120之间产生第一摩擦力，且所述医用植入物至少部分嵌入所述凹陷部，以增大所述第一摩擦力。这里所述的医用植入物例如是自膨式支架，具体可为编织支架或切割支架。
需要说明的是，为了提高带动构件120与所述医用植入物的配合度，简化治疗装置的装配过程，本实施例所述的输送导丝100优选依据具体的医用植入物进行制造。也就是说，在生产输送导丝100的过程中，首先提供待输送的医用植入物，然后根据所述医用植入物的结构确定带动构件120及凹陷部的形式，最后进行输送导丝100的制造。
另外，根据实际需要，所述输送管之内腔具有不同的径向尺寸，优选的，所述内腔的径向尺寸的范围为0.017英寸至0.029英寸。更优选的，所述内腔的径向尺寸小于或等于0.027英寸，或者所述内腔的径向尺寸小于或等于0.021英寸。由于输送导丝采用了具有凹陷部的带动构件，可以减小医用植入物在压缩状态下的外径，因而本发明的治疗装置可采用内腔的径向尺寸较小的输送管，该治疗装置可以相应地减小输送管的外径，较细的输送管可达到更远端的血管或更细小的病变部位，扩大治疗范围，同时也提高了治疗装置整体的柔顺性，更有利于通过较为迂曲的血管以顺利到达病变部位，提高手术成功率。
虽然本发明披露如上，但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。

Claims (34)

  1. 一种输送导丝，用于输送医用植入物，其特征在于，包括芯轴和设置于所述芯轴上的带动构件，所述带动构件上形成有凹陷部。
  2. 根据权利要求1所述的输送导丝，其特征在于，所述带动构件包括本体和形成于所述本体之外表面的凹槽，所述凹槽构成所述凹陷部。
  3. 根据权利要求2所述的输送导丝，其特征在于，所述凹槽的结构与压缩态的所述医用植入物的至少部分结构相匹配。
  4. 根据权利要求3所述的输送导丝，其特征在于，所述凹槽与压缩态的所述医用植入物的内表面互为镜像。
  5. 根据权利要求3所述的输送导丝，其特征在于，所述凹槽的宽度为0.0008英寸至0.004英寸，和/或，所述凹槽的深度为0.0002英寸至0.004英寸。
  6. 根据权利要求2所述的输送导丝，其特征在于，所述凹槽包括一个或多个子凹槽，多个所述子凹槽交错布置、连续布置或间隔布置于所述本体的外表面上。
  7. 根据权利要求2所述的输送导丝，其特征在于，所述凹槽沿所述本体的轴线螺旋环绕以在所述本体的外表面形成一个或多个螺旋状凹槽。
  8. 根据权利要求1所述的输送导丝，其特征在于，所述带动构件由缠绕丝沿所述芯轴的轴线螺旋环绕形成一个或多个螺旋结构，且相邻两圈的所述缠绕丝间隔布置以形成所述凹陷部。
  9. 根据权利要求8所述的输送导丝，其特征在于，所述缠绕丝为高分子丝或者表面包覆有高分子涂层的金属丝。
  10. 根据权利要求9所述的输送导丝，其特征在于，所述金属丝具有显影性，和/或，所述金属丝为铂钨合金丝或铂铱合金丝。
  11. 根据权利要求1所述的输送导丝，其特征在于，所述带动构件包括内层件和外层件，
    其中，所述内层件由金属材料制成，并固定套设于所述芯轴上；
    所述外层件由高分子材料制成，并固定套设于所述内层件上。
  12. 根据权利要求11所述的输送导丝，其特征在于，所述内层件具有空隙结构，所述外层件部分或完全填充所述空隙结构，至少部分所述外层件穿过所述空隙结构与所述芯轴连接。
  13. 根据权利要求11所述的输送导丝，其特征在于，所述内层件的外表面设置有凹陷部，所述凹陷部构成所述空隙结构。
  14. 根据权利要求11所述的输送导丝，其特征在于，所述内层件包括多个线圈，多个所述线圈沿所述芯轴的轴向依次布置，相邻的两个所述线圈之间形成有所述空隙结构。
  15. 根据权利要求11所述的输送导丝，其特征在于，所述内层件是由丝线编织而成的管网状结构，所述管网状结构的网孔构成所述空隙结构。
  16. 根据权利要求15所述的输送导丝，其特征在于，所述丝线的直径小于或等于0.001英寸，和/或，每英寸长度的所述内层件上所包含的编织交点的数量为15-50。
  17. 根据权利要求11所述的输送导丝，其特征在于，所述内层件为至少一个管状结构，所述外层件部分或完整包覆所述内层件。
  18. 根据权利要求11所述的输送导丝，其特征在于，所述内层件是由丝线沿所述芯轴的轴线螺旋环绕而形成的螺旋结构，相邻两圈的所述丝线之间形成有所述空隙结构。
  19. 根据权利要求18所述的输送导丝，其特征在于，所述丝线的直径小于或等于0.001英寸，和/或，所述丝线形成的螺旋结构的螺距为0.001-0.007英寸。
  20. 根据权利要求11-19中任一项所述的输送导丝，其特征在于，所述内层件由具有显影性的金属材料制成，其中，所述金属材料选自铂、金、钨、铂金合金、铂钨合金、铂铱合金和铂镍合金中的一种或多种。
  21. 根据权利要求11-19中任一项所述的输送导丝，其特征在于，所述内层件与所述芯轴焊接或胶结，和/或，所述外层件包覆所述内层件并延展至与所述芯轴连接。
  22. 根据权利要求11-19中任一项所述的输送导丝，其特征在于，所述外层件的材质包括嵌段聚醚酰胺树脂、热塑性聚氨酯弹性体、硅胶、尼龙和丙烯酸聚合物中的任一种或多种。
  23. 根据权利要求11-19中任一项所述的输送导丝，其特征在于，所述外层件通过热压和/或浸涂的方式形成于所述内层件上，或者所述内层件和所述外层件粘接。
  24. 根据权利要求23所述的输送导丝，其特征在于，所述凹陷部形成于所述外层件的外表面上；和/或，所述凹陷部的结构与压缩态的所述医用植入物的至少部分结构相匹配。
  25. 根据权利要求24所述的输送导丝，其特征在于，所述凹陷部包括一个或多个子凹槽，多个所述子凹槽交错布置、连续布置或间隔布置于所述外层件的外表面上。
  26. 根据权利要求1-19中任一项所述的输送导丝，其特征在于，所述芯轴上设有至少两个所述带动构件，至少两个所述带动构件沿所述芯轴的轴向间隔布置。
  27. 根据权利要求26所述的输送导丝，其特征在于，相邻两个所述带动构件之间的距离为0.5mm-150mm。
  28. 根据权利要求27所述的输送导丝，其特征在于，相邻两个所述带动构件之间的距离为0.5mm-5mm。
  29. 根据权利要求1-19中任一项所述的输送导丝，其特征在于，所述芯轴上设有一个或多个所述带动构件，所述带动构件的外径为0.01英寸-0.03英寸，每个所述带动构件的长度为0.5mm-8mm。
  30. 根据权利要求29所述的输送导丝，其特征在于，每个所述带动构件的长度为0.5mm-4mm。
  31. 根据权利要求1-19中任一项所述的输送导丝，其特征在于，还包括第一显影件和第二显影件，所述第一显影件设置于所述芯轴的远端的端部，所述第二显影件设置于所述芯轴上，所述带动构件设置于所述第一显影件与所述第二显影件之间。
  32. 一种治疗装置，其特征在于，包括输送管、医用植入物及如权利要求1-29中任一项所述的输送导丝；所述输送管具有轴向贯通的内腔，所述内腔用于容纳所述医用植入物，且所述内腔的壁对所述医用植入物产生挤压以使所述医用植入物呈压缩态；压缩态的所述医用植入物套设在所述带动构件上，且所述医用植入物至少部分嵌入所述凹陷部。
  33. 如权利要求32所述的治疗装置，其特征在于，所述内腔的径向尺寸的范围为0.017英寸至0.029英寸。
  34. 根据权利要求32所述的治疗装置，其特征在于，所述医用植入物为自膨式支架。
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